Posted by Michael Wonder on 07 Sep 2017
Drug makers push back on data requirements in Australia’s provisional approval pathway
5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for Australia's provisional approval pathway.
The concerns centre on the potential for the need to provide months of stability data and achieve good manufacturing practice clearance to limit the impact of the the pathway.
The TGA wants to set up the provisional approval pathway to enable companies to cut the time it takes for highly-promising medicines to reach patients. TGA outlined its plans for the pathway in a consultation text earlier this year and asked companies for feedback on whether they foresaw difficulties with the proposed data requirements. Companies including AbbVie, Amgen, Johnson & Johnson, Roche and Sanofi highlighted essentially the same difficulties in their responses.
Pfizer’s response to TGA is representative of the concerns these drugmakers have with the agency’s statement that “applications must include comprehensive quality and non-clinical safety modules that fulfil TGA’s mandatory data requirements.”
